Company ยท FR
Eos Imaging
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2025. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (1 in 12 months)
8recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 14, 2025 | K251078 | AutoDensity Eos Imaging, FR | QIH |
| Aug 15, 2025 | K251747 | VEA Align; spineEOS Eos Imaging, FR | QIH |
| Aug 6, 2024 | K233920 | EOSedge Eos Imaging, FR | KPR |
| Jun 25, 2024 | K240582 | VEA Align; spineEOS Eos Imaging, FR | QIH |
| Jan 5, 2024 | K231917 | VEA Align Eos Imaging, FR | QIH |
| Oct 24, 2023 | K232086 | spineEOS Eos Imaging, FR | LLZ |
| Sep 16, 2020 | K202394 | EOSedge Eos Imaging, FR | KPR |
| Nov 27, 2019 | K192079 | EOSedge Eos Imaging, FR | KPR |
| Jun 19, 2018 | K172346 | sterEOS Workstation Eos Imaging, FR | LLZ |
| Apr 22, 2016 | K160914 | sterEOS Workstation Eos Imaging, Inc., FR | LLZ |
| Oct 21, 2015 | K152788 | EOS System Eos Imaging, FR | KPR |
| Jan 22, 2015 | K142773 | EOS System Eos Imaging, FR | KPR |
| Sep 15, 2014 | K141137 | STEREOS WORKSTATION Eos Imaging | LLZ |
| Mar 11, 2013 | K130395 | STEREOS WORKSTATION Eos Imaging, Inc. | LLZ |
| Feb 22, 2013 | K123740 | EOS Eos Imaging | MQB |
| Nov 16, 2012 | K113344 | STEREOS WORKSTATION Eos Imaging | LLZ |
| Apr 6, 2012 | K120721 | EOS Eos Imaging | MQB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2020 | EOS Imaging The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. The scan length is defined by the user and may cover the whole body or a specific Terminated |
KPR | K202394 |
| Aug 1, 2018 | EOS Imaging sterEOS workstation Terminated |
LLZ | K172346 |
| May 30, 2017 | EOS Imaging ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773; and MOBELI Dual Grip Grab Handle, ROTH Catalog Terminated |
IKX | None listed |
| May 5, 2015 | Eos Imaging Inc EOS, Digital radiography system used in general radiographic examinations. Terminated |
MQB | K123740 |
| Jan 9, 2014 | EOS Imaging EOS System X- ray beam
Digital radiography system used in general radiographic examinations. Terminated |
MQB | None listed |
| Dec 26, 2013 | EOS Imaging steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images
Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and dig Terminated |
LLZ | K130395 |
| Sep 28, 2012 | Eos Imaging Inc EOS X-ray Medical Diagnostic , X-ray Equipment System
Digital Radiography used in general radiographic examination. Terminated |
MQB | None listed |
| Jun 28, 2011 | Eos Imaging Software versions
Eos software versions: 1.2.4, 1.2.5, 1.2.6,1.2.7,1.2.8, 1.2.9,1.2.10, .2.11,1.2.12, 1.2.13, 1.3.2,1.3.3, 1.3.4, 1.4.0, 1.4.1, 1.4.2.
sterEOS software versions: 1.2.3.3788, 1.2.4.428 Terminated |
LLZ | K071546 K101398 |